Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
TIZANIDINE HYDROCHLORIDE (UNII: B53E3NMY5C) (TIZANIDINE - UNII:6AI06C00GW)
STAT RX USA LLC
TIZANIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE 4 mg
ORAL
PRESCRIPTION DRUG
Tizanidine is a short-acting drug for the management of spasticity. Because of the short duration of effect, treatment with tizanidine should be reserved for those daily activities and times when relief of spasticity is most important (see DOSAGE AND ADMINISTRATION). Concomitant use of tizanidine with fluvoxamine or with ciprofloxacin, potent inhibitors of CYP1A2, is contraindicated. Significant alterations of pharmacokinetic parameters of tizanidine including increased AUC, t1/2, Cmax, increased oral bioavailability and decreased plasma clearance have been observed with concomitant administration of either fluvoxamine or ciprofloxacin. This pharmacokinetic interaction can result in potentially serious adverse events (See WARNINGS and CLINICAL PHARMACOLOGY: Drug Interactions). Zanaflex is contraindicated in patients with known hypersensitivity to Zanaflex or its ingredients. Tizanidine should be used with caution in elderly patients because clearance is decreased four-fold. There are no adequate an
Zanaflex Capsules® (tizanidine hydrochloride) are available in three strengths as two-piece hard gelatin capsules containing tizanidine hydrochloride 2 mg, 4 mg or 6 mg. The 2 mg capsules have a standard blue opaque body with a standard blue opaque cap with "2 MG" printed on the cap. The 4 mg capsules have a white opaque body with a standard blue opaque cap with "4 MG" printed on the cap. The 6 mg capsules have a light blue opaque body with a white stripe and light blue opaque cap with "6 MG" printed on the capsules. The capsules are provided as follows: Zanaflex Capsules® (tizanidine hydrochloride), 2 mg, bottles of 150 capsules (NDC 10144-602-15) Zanaflex Capsules® (tizanidine hydrochloride), 4 mg, bottles of 150 capsules (NDC 10144-604-15) Zanaflex Capsules® (tizanidine hydrochloride), 6 mg, bottles of 150 capsules (NDC 10144-606-15) Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Dispense in containers with child resistant closure Zanaflex® (tizanidine hydrochloride) tablets are available in one strength as white, uncoated tablets containing tizanidine hydrochloride 4 mg. The 4 mg tablets have a quadrisecting score on one side and are debossed with "A594" on the other side. Tablets are provided as follows: Zanaflex® (tizanidine hydrochloride) tablets, 4 mg, bottles of 150 tablets (NDC 10144-594-15) Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Dispense in containers with child resistant closure Rx Only Zanaflex® is the registered trademark of Acorda Therapeutics, Inc. Zanaflex Capsules® is the trademark of Acorda Therapeutics, Inc. Marketed and Distributed by: Acorda Therapeutics, Inc. Hawthorne, NY 10532 ©2008, Acorda Therapeutics, Inc., All rights reserved. Rev. 04/08
New Drug Application
ZANAFLEX - TIZANIDINE HYDROCHLORIDE CAPSULE STAT RX USA LLC ---------- PHARMACOKINETIC DIFFERENCES BETWEEN ZANAFLEX CAPSULES AND ZANAFLEX TABLETS: ZANAFLEX CAPSULES ARE NOT BIOEQUIVALENT TO ZANAFLEX TABLETS IN THE FED STATE. THE PRESCRIBER SHOULD BE THOROUGHLY FAMILIAR WITH THE COMPLEX EFFECTS OF FOOD ON TIZANIDINE PHARMACOKINETICS (SEE PHARMACOKINETICS AND DOSAGE AND ADMINISTRATION). DESCRIPTION Zanaflex (tizanidine hydrochloride) is a centrally acting α -adrenergic agonist. Tizanidine HCl (tizanidine) is a white to off-white, fine crystalline powder, which is odorless or with a faint characteristic odor. Tizanidine is slightly soluble in water and methanol; solubility in water decreases as the pH increases. Its chemical name is 5-chloro-4-(2-imidazolin-2-ylamino)-2,1,3-benzothiodiazole hydrochloride. Tizanidine's molecular formula is C H ClN S-HCl, its molecular weight is 290.2 and its structural formula is: Zanaflex Capsules are supplied as 2, 4, and 6 mg capsules and Zanaflex tablets are supplied as 4 mg tablets for oral administration. Zanaflex Capsules are composed of the active ingredient, tizanidine hydrochloride (2.29 mg equivalent to 2 mg tizanidine base, 4.58 mg equivalent to 4 mg tizanidine base, and 6.87 mg equivalent to 6 mg tizanidine base), and the inactive ingredients, hydroxypropyl methyl cellulose, silicon dioxide, sugar spheres, titanium dioxide, gelatin, and colorants. Zanaflex tablets are composed of the active ingredient, tizanidine hydrochloride (4.58 mg equivalent to 4 mg tizanidine base), and the inactive ingredients, silicon dioxide colloidal, stearic acid, microcrystalline cellulose and anhydrous lactose. CLINICAL PHARMACOLOGY ® ® ® ® ® 2 9 8 5 ® ® ® ® MECHANISM OF ACTION Tizanidine is an agonist at α -adrenergic receptor sites and presumably reduces spasticity by increasing presynaptic inhibition of motor neurons. In animal models, tizanidine has no direct effect on skeletal muscle fibers or the neuromuscular junction, and no major effect on monosynaptic spinal reflexes. Th Preberite celoten dokument